The invention generally relates to a combination of otolaryngological devices and introducers for positioning such devices within a patient's otolaryngological cavity. In particular, the invention relates to kits and methods that use introducers to engage stents through frictional forces and that position and release such stents in Eustachian tubes to render the tubes patent.
Otolaryngology is a branch of medicine and surgery that specializes in the diagnosis and treatment of ear, nose, throat, and head and neck disorders. Otolaryngologists are trained to provide comprehensive medical and surgical care for patients with diseases and disorders that affect the ears, nose, throat, the respiratory and upper alimentary systems, and related structures of the head and neck. For example, an otolaryngologist may provide expertise in head and neck oncology, facial plastic and reconstructive surgery, otology, rhinology, and laryngology. Other recognized otolaryngological subspecialities include, for example, neurotology, pediatric otolaryngology, and sleep medicine.
Numerous techniques and devices have been developed to treat various otolaryngological conditions and to help improve bodily function. For example, sinusitis, i.e., inflammation or infection of the paranasal sinuses, may be treated in a number of ways. Typically, initial treatment involves using anti-inflammatory agents to reduce the inflammation. Often, the infection is due to a bacterial source, and antibiotics are added. When unresponsive to drug therapy, chronic sinusitis may require endoscopic surgery. Under visualization through the endoscope, the surgeon may remove tissue to provide sufficient patency of sinus passageways to allow for their drainage. In addition to endoscopes, such surgery may involve the use of known devices e.g., cutting debriders, tubular guides, catheters, etc.
Recently, a number of patents have described surgical procedures involving the use of medical devices having balloon catheters. For example, patents relating to surgeries and other sinus treatments involving balloon dilation include, e.g., U.S. Pat. Nos. 7,803,150, 7,771,409, 7,753,930, 7,753,929, 7,740,642, 7,727,226, 7,727,186, 7,720,521, 7,717,933, 7,654,997, 7,648,367, 7,645,272, 7,559,925, 7,500,971, and 7,462,175. These patents generally describe flexible inflatable pressure devices that may be inserted and inflated within the sinuses. Although the devices may be navigated through the complex anatomy of the sinuses and the procedures for deploying such devices are described as minimally invasive, the devices are generally complex in construction.
In contrast, stents are often simpler in construction than their inserters. For example, U.S. Pat. No. 5,246,455 to Shikani describes a hole-type stent in the form of middle meatal antrostomy ventilation tube for use following endoscopic surgery. The tube consists of a pair of flanges and a central tubular vent section extending therebetween. The flanges are positioned perpendicular to the lumen of the central tubular vent section and serve to immobilize the tube within the antrostomy.
In addition, stents may be used for other otolaryngological procedures. For example, lumen-type stents may be used to treat chronic otitis media, which occurs when the Eustachian tube fails to ventilate the middle ear over an extended period. In these cases, fluid and thickened mucosa accumulate in the middle ear, causing hearing loss. Treatment of complications from Eustachian tube dysfunction, such as chronic otitis media may involve ventilation of the middle ear by incising the eardrum or tympanic membrane. Alternatively, as described in U.S. Pat. No. 6,589,286 to Litner, an elongate Eustachian tube stent that may be used concomitantly with middle ear surgery.
More recently, U.S. Pat. No. 7,833,282 to Mandpe describes Eustachian tube devices for insertion into a Eustachian tube without need for surgical incisions. The devices are generally considered a lumen-type stent and may include an insertable member, an immobilizing means and a fluid-communication providing means. Also provided are kits that include the device and methods for inserting the device into a Eustachian tube. Such kits may include endoscopic or other insertors for use with the Eustachian tube devices.
Nevertheless, opportunities exist to overcome disadvantages associated with known otolaryngological technologies. Specifically, opportunities exist in the art for a combination of improved introducers and Eustachian tube devices, the combination having a simple yet effective construction that allows for manipulating and positioning otolaryngological devices such as stents during medical and/or surgical procedures.